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Nonetheless, the fees may come up to a substantial amount when the manufacturer applies, for example, for reimbursement of a family of related devices. The MoH intends on separating the two [ 27 ], which will increase the flexibility and efficiency of defining drug programmes — a proposal well-received by the industry [ 34 ]. What to expect next year? The proposed changes relax reimbursement criteria for ultra-orphan drugs, focusing them on price justification rather than economic analysis, which may improve access to these medications. The project proposes to combine the three different reimbursement categories outlined above using a single approach, whereby the reimbursement of all medical devices would be aligned with that of drugs [ 1 ]. The proposed reimbursement mechanism is similar to that for drugs, requiring an application from the manufacturer, followed by a HTA and pricing negotiations, before the MoH issues a decision [ 27 ]. Next product. Remember me. Poland has operated a national vaccination programme since the s [ 30 ]. May 8,

The amendment introduces the concept of compassionate use in Poland — a change that has been well received by the industry [ 34 ]. Poland has operated a national vaccination programme since the s [ 30 ]. Group tenders are not as common in Poland as they are in many other countries, although public hospital managers have been growing more in favour of them lately [ 10 ]. Hoping to improve patient access, the amendment introduces partial reimbursement for vaccines that are recommended, but not mandatory. Devices issued based on special prescription — separate reimbursement rules apply e.

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The proposed reimbursement mechanism is similar to that for drugs, requiring an application from the manufacturer, followed by a HTA and pricing negotiations, before the MoH issues a decision [ 27 ]. The fixed prices and margins that affect drugs and simple devices sold in pharmacies do not apply to this device group, which is freely priced, often leading to excess pricing of reimbursed devices [ 1 ]. Closely linked to reimbursement decisions for included products, so that any changes need approval of all affected manufacturers. Take 10 minutes, gather courage and test in the comfort of your home for cervical and genital wart cancer. As some patients may be unable to afford out-of-pocket payments for more expensive products [ 18 , 20 , 21 ], care should be taken to provide patients with a reasonable range of high-quality, affordable devices priced within, or only slightly above, the reimbursement limit. Fidelity test to reveal infidelity Detects PSA antigen Incredibly accurate test method The test does not damage the material in any way It leaves no traces on the objects! Finally, devices such as prostheses, infusion sets for insulin pumps, glasses and hearing aids, among others, require a special prescription from an appropriate specialist, which has to be approved by the NHF regional office 2 before the device can be reimbursed [ 1 , 14 , 15 ]. Thus, the amendment establishes a fixed margin for exporters in an attempt to make pharmaceutical export less profitable and, consequently, limit it [ 3 , 34 ]. However, in the private sector, group tenders are commonplace; a single tender may cover supplies for a whole network of private hospitals and outpatient clinics [ 10 ]. Thus, products for which risk-sharing instruments are in place — that is, mostly novel, expensive treatments — will be exempt from payback [ 27 ]. Importantly, devices used as part of a procedure — which are currently included in a bundle payment with the procedure itself — will go through their own, separate pricing and reimbursement process [ 1 ]. Key highlights The proposed changes introduce uniform reimbursement mechanisms for all medical devices, replacing the three distinct reimbursement groups currently in place. Furthermore, issues such as the reimbursement of drugs for orphan diseases are not addressed in the proposed amendments, and some of the new regulations e. Furthermore, the proposed application fees might be a concern for some, especially smaller, companies [ 18 , 21 ]. At the moment, the drug programmes and the relevant reimbursement decisions are linked, so that implementing any changes to the programme itself requires the permission of all manufacturers whose products are included in it [ 27 ].

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• To allow manufacturers to smoothly transfer their currently reimbursed devices to the new system, the MoH will allow them to do so on preferential terms.
• Similarly to other healthcare systems in Europe and around the world, the Polish healthcare system faces substantial cost constraints.
• The programme is revised annually and an updated version is published every year by the Chief Sanitary Inspectorate [ 30 ].
• April [cited Feb].

Federal government websites often end in. The site is secure. In Poland, two proposed amendments to the reimbursement act are currently in preparation; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Nonetheless, the overall direction of some of the changes is already evident and warrants discussion due to their high expected impact on pharmaceutical and device manufacturers. Here we evaluate the main changes proposed to the reimbursement of drugs, vaccines, and medical devices, and examine the impact they are likely to have on market access and pharmaceutical industry in Poland. The reimbursement system in Poland is soon likely to change significantly, with two amendments to the reimbursement act currently under discussion. The first amendment relates to the reimbursement of medical devices, aligning it with that of pharmaceuticals [ 1 ], while the other one proposes major changes to the overall reimbursement system for drugs and vaccines [ 2 ]. Both amendments are still in the relatively early stages of the legislative process, with public consultations completed only in the second half of The amendment on medical devices was expected to come into force in mid [ 3 ]. Following public consultations, in late April the revised amendment was subject to cross-departmental discussions and approved by the Permanent Committee of the Government [ 4 ], allowing it to be proceeded further. However, as the deadlines for the next legislative steps are not fixed, the actual timeline for implementation is hard to predict. The timeline for the general amendment is also unclear. Major changes to the pricing and reimbursement regulations included in these amendments are listed in Table 1. This article aims to review the key changes proposed to the reimbursement of drugs, vaccines, and medical devices, and assess their potential impact on market access and pharmaceutical industry in Poland. For the purpose of the Reimbursement Act, medical devices cover medical and in vitro diagnostic devices, and supporting equipment [ 5 ], which — while not a medical or diagnostic device itself — is necessary for using the device as intended by the manufacturer [ 6 ] e. It is worth noting here that Poland uses a broad definition of medical devices. According to the Medical Devices Act [ 6 ], a medical device is. From this definition, it is clear that the proposed changes to medical device reimbursement will affect a wide range of products, including, but not limited to, therapeutic, diagnostic and implantable devices.

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Changes to medical device reimbursement

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Risk-sharing instruments and payback applied to health products The proposed amendment changes the way in which the reimbursement budget is formed to include income from risk-sharing instruments and payback [ 27 ].

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